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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Gene mutation in vitro:

Ames assay was performed to determine the mutagenic nature of Prussian blue. The study was performed using bacteria. Prussian blue did not induce gene mutation in bacterial strain used in the study and hence it is not likely to classify as a gene mutant in vitro.

Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from HSDB
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
Gene mutatoin toxicity study was performed to determine the toxic nature of Prussian Blue
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Specific details on test material used for the study:
- Name of test material: Prussian blue
- IUPAC name: C.I. Pigment Blue 27
- Molecular formula: C6FeN6.4/3Fe
- Molecular weight: 859.23 g/mol
- Smiles : [CH-](#N)[Fe+2]([CH-]#N)([CH-]#N)([CH-]#N)([CH-]#N)[CH-]#N.[CH-](#N)[Fe+2]([CH-]#N)([CH-]#N)([CH-]#N)([CH-]#N)[CH-]#N.[CH-] (#N)[Fe+2]([CH-]#N)([CH-]#N)([CH-]#N)([CH-]#N)[CH-]#N.[Fe+3].[Fe+3].[Fe+3].[Fe+3]
- InChI : 1S/18CN.7Fe/c18*1-2;;;;;;;/q18*-1;3*+2;4*+3
- Substance type: Inorganic
- Physical state: Solid powder (dark blue)
Target gene:
No data
Species / strain / cell type:
bacteria, other:
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Cytokinesis block (if used):
No data
Metabolic activation:
not specified
Metabolic activation system:
No data
Test concentrations with justification for top dose:
No data
Vehicle / solvent:
No data
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
not specified
Positive control substance:
not specified
Details on test system and experimental conditions:
No data
Rationale for test conditions:
No data
Evaluation criteria:
The plates were observed for a dose dependent increase in the number of revertants/plate
Statistics:
No data
Species / strain:
bacteria, other:
Metabolic activation:
not specified
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
No data
Remarks on result:
other: No mutagenic potential
Conclusions:
Prussian blue did not induce gene mutation in bacterial strain used in the study and hence it is not likely to classify as a gene mutant in vitro.
Executive summary:

Ames assay was performed to determine the mutagenic nature of Prussian blue. The study was performed using bacteria. Prussian blue did not induce gene mutation in bacterial strain used in the study and hence it is not likely to classify as a gene mutant in vitro.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Gene mutation in vitro:

Ames assay was performed (HSDB, 2018) to determine the mutagenic nature of Prussian blue (CAS no 14038 -43 -8). The study was performed using bacteria. Prussian blue did not induce gene mutation in bacterial strain used in the study and hence it is not likely to classify as a gene mutant in vitro.

Data available from the functionally similar read across chemicals C.I. Pigment Blue 27 (RA CAS no 12240 -15 -2) and Potassium ferricyanide (RA CAS no 13746 -66 -2) has been used and the weight of evidence approach has been applied to futher support the mutagenic nature of target chemical. The studies are as mentioned below:

Gene mutation study was conducted by Milvy and Kay ( Journal of Toxicology and Environmental Health, 1979) to evaluate the mutagenic nature of read across chemical Iron blue (RA CAS no 12240 -15 -2; IUPAC name: C.I. Pigment Blue 27). The study was performed using the preincubation protocol using Salmonella typhimurium TA98, TA1538 and TA1535 both in the presence and absence of S9 metabolic activation system.10 µg of the dye partially or completely dissolved in 0.01 ml of dimethyl sulfoxide (DMSO) was added to 0.9 ml of the reagents in the liquid phase and incubated 30 min at 37°C with shaking before plating 0.1 ml onto minimal plates.Ironbluedid not induce mutation in theSalmonella typhimurium TA98, TA1538 and TA1535 in the presence and absence of S9 metabolic activation system and hence is negative for gene mutation in vitro.

Rec assay was performed by Kanematsu et al (Mutation Research, 1980) by the cold intubation process was conducted to evaluate the mutagenic nature of the 84.1% struturally similar reas across chemical Potassium ferricyanide (RA CAS no 13746 -66 -2; IUPAC name: tripotassium;iron(3+);hexacyanide). The test chemical was dissolved in distilled water and used at dose levels of 0.005-0.5M. The study was performed using Bacillus subtilis strains H17 and M45. A 0.05-ml portion of each metal solution (0.005-0.5 M) was dropped onto a filter paper disk (diameter 10 mm), and the disk was placed on the starting point of the streak. The plates were kept at 4°C for 24 h and then incubated at 37°C overnight. The above "cold incubation" inserted between drug administration and 37°C incubation increases the assay sensitivity about 20-50 times for many drugs. When the DNA damage is produced by a chemical and subjected to cellular recombination-repair function, the growth of recombination deficient cells is usually inhibited much more than that of wild cells. Based on the observations made, Potassium ferricyanide did not induce gene mutation in the H17 and M45 strains of Bacillus subtilis and hence it is not likely to classify as a gene mutant in vitro.

Based on the data available for the read across chemical and applying the weight of evidence approach, iron(2+);iron(3+);octadecacyanide is not likely to classify as a gene mutant in vitro.

Justification for classification or non-classification

Based on the data available for the read across chemical and applying the weight of evidence approach, iron(2+);iron(3+);octadecacyanide (CAS no 14038 -43 -8) is not likely to classify as a gene mutant in vitro.